Submission instructions to Infarmed

PAES studies to be carried out exclusively in Portugal in fulfillment of an obligation

Must be submitted to Infarmed for evaluation studies conducted in compliance with an obligation imposed in accordance with Article 26a of Decree-Law No. 128/2013, of September 5 to be realized exclusively in Portugal.

Before performing a study the marketing authorization holder has to submit to INFARMED, IP, a protocol design.

Within 60 days of the submission of the draft protocol, INFARMED, IP, adopt and notify the marketing authorization holder of its decision.

The study may commence only after the approval of INFARMED, IP.

Amendments

1 - After the start of a study, any substantial amendments the protocol must be submitted by the marketing authorization holder to INFARMED, IP, prior to implementation.

2 - INFARMED, IP, assess the amendments and inform the marketing authorisation holder of its endorsement or objection.

Completion of study

Upon completion of the study, ie after the end of data collection, the marketing authorization holder has within 12 months, to submit the final report and the summary of the final report.

All relevant documentation should be submitted through RNEC, as provided in the document 'Technical requirements and functional specifications' according to Article 10 of Decree No. 65/2015, of March 5.